1. Field of the Invention
The present invention relates generally to medical devices and methods. More particularly, the present invention relates to a balloon catheter having an exchangeable balloon structure.
Percutaneous transluminal angioplasty procedures have become a therapy of choice for treating stenosed regions in the patient's vasculature, particularly the coronary vasculature. Recently, the use of such angioplasty procedures has often been combined with stent placement and/or radiation treatment to inhibit restenosis and hyperplasia following angioplasty. When performing such multiple, sequential treatments, it is usually necessary to “exchange” catheters which are used to perform each of the procedures. That is, the initial angioplasty treatment will be performed using a balloon angioplasty catheter. After the angioplasty is completed, a second catheter carrying a stent or other vascular prosthesis must then be introduced to the treatment site. Introduction of the second catheter involves first removing the balloon angioplasty catheter and then placing the second catheter in the treatment region. Optionally, a third catheter may then be exchanged for the second in order to perform radiation or other treatments in order to inhibit hyperplasia.
In performing such multiple, sequential treatments, most physicians prefer to leave a “guidewire” in place to the treatment location. A guidewire is a small diameter, highly flexible wire that can be steered to the target location through the vasculature and which then acts as a guide path for introducing and positioning the balloon angioplasty and other interventional catheters.
In the early days, balloon angioplasty catheters were designed to be introduced into the vasculature in an “over-the-wire” manner. That is, the catheters were designed to have passages, commonly referred to as guidewire lumens, which extended the entire distance from the distal end of the catheter to the proximal end of the catheter. The catheter could then be loaded over a proximal end of a guidewire which was already in place in the patient and then advanced over the guidewire until a distal end of the catheter reached the target site. While functional, the need to maintain control of the guidewire while the interventional catheter was being introduced meant that the guidewire had to have an excess length outside of the patient which was greater than the length of the catheter being introduced. If the length were any shorter, the treating physician would not be able to hold on to the guidewire as the catheter was being introduced. Although necessary for catheter introduction, the excess guidewire length (optionally in the form of a detachable extension) was very difficult to manage during other parts of the treatment.
To overcome the difficulties associated with very long guidewires “rapid exchange” or “monorail” balloon angioplasty catheters were developed. A number of specific designs have been developed over the years, and the rapid exchange catheters generally have a shortened guidewire lumen which extends from a distal tip of the catheter to an exit port located closer to the distal end of the catheter than to the proximal end. By reducing the length of the guidewire lumen, the need for a guidewire having excess length outside of the patient is also reduced.
The use of rapid exchange catheters has become wide spread, and they have proven to be particularly valuable for use as stent delivery catheters. Stent delivery catheters are normally used after an initial angioplasty treatment. In such cases, the angioplasty catheter will be removed and exchanged for the stent delivery catheter. Use of an angioplasty catheter having a rapid exchange design facilitates removal of the angioplasty catheter over short guidewires. Similarly, use of the stent delivery catheter having a rapid exchange design facilitates introduction of the catheter over the guidewire which remains in place in the patient.
Despite their widespread acceptance, rapid exchange catheters suffer from a number of limitations. In particular, the shortened guidewire lumens reduce the “pushability” of the rapid exchange catheters. The use of full length guidewire lumens as provided by the over-the-wire designs results in an overall increase in the column strength of the catheter being introduced. That is, the catheter derives column strength not only from the catheter body itself, but also from the guidewire which is in place in the guidewire lumen over the entire length of the catheter, allowing better access across tight lesions. Additionally, presence of the guidewire in a full length guidewire lumen lessens the risk of the catheter body kinking or collapsing in tortuous regions of the vasculature. Kinking can be a particular problem at the point where the guidewire exits a catheter body in a rapid exchange design.
The second problem associated with the use of rapid exchange catheters is the inability to exchange the guidewire. Guidewire exchange in over-the-wire catheters is quite simple since the guidewire lumen extends the fall length of the catheter body. In rapid exchange catheters, in contrast, there is no guidewire lumen in the proximal portions of the angioplasty catheter. It is therefore difficult to reintroduce a guidewire into the shortened guidewire lumen of the rapid exchange catheter.
For these reasons, it would be desirable to provide improved apparatus, methods, and kits which permit the exchange of catheters and catheter components over shortened guidewires. Particularly, it would be desirable to provide improved balloon angioplasty and other catheters which can be introduced to the vasculature in the manner of an over-the-wire catheter, but which allow removal of the catheter over a shortened guidewire and/or which permits exchange of catheter components over the catheter body which remains in place over the guidewire. It would be further desirable to provide balloon catheters and methods for their use which permit exchange of balloon structures over the catheter body while the catheter body remains in place in the vasculature over a guidewire and where the replacement balloon structure may optionally carry a stent. At least some of these objectives will be met by the invention described in claims herein after.
2. Description of the Background Art
Rapid exchange catheters having guidewire exchange devices are described in U.S. Pat. Nos. 5,281,203; 5,571,094; and 5,919,175. Sleeves for positioning stents, drug infusion tubes, imaging transducers, and other interventional devices over balloon angioplasty catheters are described in U.S. Pat. No. 5,776,191; 5,810,869; and PCT Publication W097/07756. Rapid exchange and related catheters are described in U.S. Pat. Nos. 6,056,722; 6,007,517; 5,980,4861; 5,947,927; 5,921,971; 5,919,164; 5,891,056; 5,846,246; 5,833,659; 5,830,227; 5,827,241; 5,807,355; 5,814,061; 5,769,868; 5,855,685; 5,749,888; 5,738,667; 5,728,067; 5,709,658; 5,685,312; 5,626,600; 5,620,417; 5,607,406; 5,554,118; 5,545,134; 5,531,690; 5,501,227; 5,472,425; 5,468,225; 5,460,185; 5,458,613; 5,451,223; 5,413,559; 5,395,335; 5,383,853; 5,364,376; 5,350,395; 5,346,505; 5,336,184; 5,334,147; 5,328,472; 5,300,085; 5,380,283; 5,263,963; 5,232,445; 5,195,978; 5,135,535; 5,061,273; 5,040,548; 4,762,129; 4,988,356; 4,947,864; 4,748,982; and WO 99/13935.